A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of GUT RESET Capsules in Alleviating the Gastro-Esophageal Reflux (GER)-Related Symptoms. ? - NI

Herbal Creations (A Unit of Kumaon Exports Pvt. Ltd.)0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1. Apparently healthy adults of any gender 18 - 60 years of age, willing to provide consent affected by symptoms of GER.
•2. History of GER-related symptoms for at least 1 month prior to study inclusion and otherwise healthy
•3. Not participated in any other interventional trials in the last 1 month before trial recruitment
•4. Willing to discontinue medications like H2 Receptor antagonists, Antacids, Pro-kinetics, and supplements that have been prescribed for the GER related symptoms and not on any of these agents in the last 10 days before randomization.
•5. Presence of symptoms of at least 2 days in the week preceding randomization

•1. Presence of any of the following red flag symptoms such as Iron deficiency anemia, weight loss, persistent vomiting, GI bleed, epigastric mass
•2. Women of reproductive age who are pregnant / lactating / not willing for adequate contraception.
•3. History of allergy to any medications including alternate system of medications
•4. History of uncontrolled diabetes (Random Blood Sugar > 200mg%)
•5. Inability to follow the protocol or expressed inability to complete all follow-ups.
•6. Abnormalities in the liver function tests (defined as total bilirubin >1mg% or SGOT / SGPT > 3 times the upper limit of normal)
•7. Abnormal renal function test (Creatinine > 1.4mg%)
•8. Congestive cardiac failure and other medical conditions which the investigator feels will affect the pharmacokinetic parameters of the study drug.
•9. History of erosive esophagitis, Barrett’s esophagus, tumoral pathologies, atypical pathology without heartburn and ulcer
•10. Presence of HIV, HbsAG or HCV positive and any other medical/ surgical condition the investigator feels may cause harm to the participant.

发起方

Herbal Creations (A Unit of Kumaon Exports Pvt. Ltd.)